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Clinical Trials (PDQ®)

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careActive18 and overPharmaceutical / IndustryLX1606.1-301-CS
LX1606.301, NCT01677910

Trial Description

Summary

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

Eligibility Criteria

Inclusion Criteria:

  • Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
  • Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period
  • Currently receiving stable-dose somatostatin analog (SSA) therapy
  • Minimum dose of LAR or depot SSA therapy
  • Octreotide LAR at 30 mg every 4 weeks
  • Lanreotide Depot at 120 mg every 4 weeks
  • Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome
  • Karnofsky Performance status ≤60%
  • Treatment with any tumor directed therapy, including interferon, chemotherapy, mTOR inhibitors ≤4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking ≤12 weeks prior to Screening
  • History of short bowel syndrome (SBS)
  • Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study, or QTcF >450 ms
  • Previous exposure to telotristat etiprate

Trial Contact Information

Trial Lead Organizations/Sponsors

Lexicon Pharmaceuticals, Incorporated

Doug Fleming, MDStudy Director

Shanna Jackson, Project managerPh: 281-863-3000
  Email: clinicalinfo@lexpharma.com

Trial Sites

U.S.A.
Alabama
  Mobile
 Lexicon Investigational Site
California
  San Francisco
 Lexicon Investigational Site
  Stanford
 Lexicon Investigational Site
Florida
  Orlando
 Lexicon Investigational Site
Iowa
  Iowa City
 Lexicon Investigational Site
Kentucky
  Lexington
 Lexicon Investigational Site
Louisiana
  Kenner
 Lexicon Investigational Site
Massachusetts
  Boston
 Lexicon Investigational Site
Nebraska
  Omaha
 Lexicon Investigational Site
New York
  Buffalo
 Lexicon Investigational Site
  New York
 Lexicon Investigational Site
Texas
  Fort Worth
 Lexicon Investigational Site
  Houston
 Lexicon Investigational Site
  McAllen
 Lexicon Investigational Site
Australia
  Freemantle
 Lexicon Investigational Site
  Woodville South
 Lexicon Investigational Site
New South Wales
  Kogara
 Lexicon Investigational Site
  St. Leanoards
 Lexicon Investigational Site
Queensland
  Herston
 Lexicon Investigational Site
Victoria
  Fitzroy
 Lexicon Investigational Site
Belgium
  Edegem
 Lexicon Investigational Site
  Gent
 Lexicon Investigational Site
  Yvoir
 Lexicon Investigational Site
Canada
Alberta
  Calgary
 Lexicon Investigational Site
Nova Scotia
  Halifax
 Lexicon Investigational Site
France
  Clichy
 Lexicon Investigational Site
  Lille
 Lexicon Investigational Site
  Lyon
 Lexicon Investigational Site
  Marseille
 Lexicon Investigational Site
  Strasbourg
 Lexicon Investigational Site
  Villejuif
 Lexicon Investigational Site
Germany
  Bad Berka
 Lexicon Investigational Site
  Berlin
 Lexicon Investigational Site
  Essen
 Lexicon Investigational Site
  Heidelberg
 Lexicon Investigational Site
  Lubeck
 Lexicon Investigational Site
  Mainz
 Lexicon Investigational Site
  Marburg
 Lexicon Investigational Site
  Munchen
 Lexicon Investigational Site
  Neuss
 Lexicon Investigational Site
Italy
  Bologna
 Lexicon Investigational Site
  Ferrara
 Lexicon Investigational Site
  Modena
 Lexicon Investigational Site
  Napoli
 Lexicon Investigational Site
  Orbassano
 Lexicon Investigational Site
  Perugia
 Lexicon Investigational Site
  Pisa
 Lexicon Investigational Site
  Rome
 Lexicon Investigational Site
Netherlands
  Amsterdam
 Lexicon Investigational Site
  Noord-Brahant
 Lexicon Investigational Site
  Noord-Holland
 Lexicon Investigational Site
  Zuid-Holland
 Lexicon Investigational Site
Spain
  Barcelona
 Lexicon Investigational Site
  Madrid
 Lexicon Investigational Site
  Seville
 Lexicon Investigational Site
Sweden
  Lund
 Lexicon Investigational Site
  Uppsala
 Lexicon Investigational Site
United Kingdom
  Basingstoke-Hampshire
 Lexicon Investigational Site
  Coventry
 Lexicon Investigational Site
  Glasgow
 Lexicon Investigational Site
  Headington-Oxford
 Lexicon Investigational Site
  London
 Lexicon Investigational Site
  Manchester
 Lexicon Investigational Site
  Newcastle upon Tyne
 Lexicon Investigational Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01677910
ClinicalTrials.gov processed this data on September 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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